Headache After Diagnostic Lumbar Puncture (HELPUmeå)

May 20, 2019 updated by: Jonatan Salzer

The Importance of Needle Size, Needle Design and Stylet Reinsertion to Prevent Post-lumbar Puncture Headache, a Randomized Controlled Trial

The objectives of this study are to investigate the effects of needle design, needle size and stylet reinsertion on the risk for headache after diagnostic LP (lumbar puncture, Post-LP headache). The following needles are used in the study:

  1. Sprotte 25 Gauge (G) (0.5 mm) atraumatic needle with introducer
  2. Sprotte 22 G (0.7 mm) atraumatic needle with introducer
  3. Spinocan 25 G (0.5 mm) cutting needle

Study Overview

Study Type

Interventional

Enrollment (Actual)

1000

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects undergoing diagnostic LP during their neurological work-up at Umeå University Hospital, Sweden, from 28 May 2013 until the study is fully recruited and;
  • Willing to participate and
  • Providing informed consent

Exclusion Criteria:

-Subjects unable to participate in the study follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sprotte 25G needle, stylet reinserted
Lumbar puncture with small bore atraumatic needle, stylet reinserted before needle withdrawal
Experimental: Sprotte 25G needle, stylet not reinserted
Lumbar puncture with small bore atraumatic needle, stylet not reinserted before needle withdrawal
Experimental: Sprotte 22G needle, stylet reinserted
Lumbar puncture with larger bore atraumatic needle, stylet reinserted before needle withdrawal
Experimental: Sprotte 22G needle, stylet not reinserted
Lumbar puncture with larger bore atraumatic needle, stylet not reinserted before needle withdrawal
Experimental: Spinocan 25G needle, stylet reinserted
Lumbar puncture with small bore cutting needle, stylet reinserted before needle withdrawal
Experimental: Spinocan 25G needle, stylet not reinserted
Lumbar puncture with small bore cutting needle, stylet not reinserted before needle withdrawal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Odds ratio for post-lumbar puncture headache (any)
Time Frame: Up to 14 days after LP
Any post-lumbar puncture headache (as defined in the international classification of headache disorders 3 (ICHD-3).
Up to 14 days after LP

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Odds ratio for post-lumbar puncture headache (severe)
Time Frame: Up to 14 days after LP
Severe (preventing daily activities) post-lumbar puncture headache (as defined in the international classification of headache disorders 3 (ICHD-3).
Up to 14 days after LP
Headache duration (days)
Time Frame: Until cessation, up to 14 days after LP
Until cessation, up to 14 days after LP
Proportion using analgesia
Time Frame: During post-lumbar puncture headache, up to 14 days after LP
During post-lumbar puncture headache, up to 14 days after LP
Proportion on sick leave
Time Frame: During post-lumbar puncture headache, up to 14 days after LP
During post-lumbar puncture headache, up to 14 days after LP
Proportion with back pain
Time Frame: Up to 14 days after LP
Up to 14 days after LP
Proportion with radiating leg pain
Time Frame: Up to 14 days after LP
Up to 14 days after LP
Multiplicative interactions between age (years), sex, BMI and needle visavi the outcome "any post-LP headache" in a multivariable logistic regression model
Time Frame: Up to 14 days after LP
Interactions between important predictors of headache and needle allocation, assessed in multivariable logistic regression models with interaction terms which are the products of the two potentially interacting variables. Age and BMI will be treated as continuous variables, sex and needle allocation as categorical variables.
Up to 14 days after LP

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure duration (minutes)
Time Frame: During the lumbar puncture
Procedure duration from start of procedure (defined as when the operator starts palpating the iliac crest) until procedure cessation (defined as when the needle is withdrawn from the participant).
During the lumbar puncture
Proportion undergoing needle switch
Time Frame: During the lumbar puncture
Technical difficulties may differ between needles and thus the proportion undergoing needle switch due to these difficulties may differ.
During the lumbar puncture
Opening pressure (cm H2O)
Time Frame: During the lumbar puncture
Opening pressure measured immediately after cerebrospinal fluid (CSF) contact using a thin tube attached to a paper ruler, using the skin entry hole as reference point. This is only performed in the recumbent position.
During the lumbar puncture

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2013

Primary Completion (Actual)

June 24, 2018

Study Completion (Actual)

October 11, 2018

Study Registration Dates

First Submitted

May 2, 2019

First Submitted That Met QC Criteria

May 20, 2019

First Posted (Actual)

May 23, 2019

Study Record Updates

Last Update Posted (Actual)

May 23, 2019

Last Update Submitted That Met QC Criteria

May 20, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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